Clinical Evaluation Plan Overview
In the field of medical writing, a Clinical Evaluation Plan (CEP) is a formal document that delineates the systematic approach employed to assess the safety, performance, and efficacy of a medical device or pharmaceutical product. All medical devices marketed in European Union (EU) member state countries must undertake a clinical evaluation in compliance with the EU Medical Devices Regulations (EU MDR) 2017/745.
A well-structured and articulate Clinical Evaluation Plan (CEP) plays a vital role in the assessment of medical devices in EU member states, aligning with the General Safety and Performance Requirements outlined in the Medical Device Regulation (EU 2017/745). This plan is essential for effectively planning and documenting the clinical evaluation process and evidence generation process for all device classifications (Class I to III), encompassing both new and existing devices. However, it is more than just a ‘check box’. It is a vital tool for ensuring that clinical evaluations are performed properly and according to a process laid out in advance.
EU MDR Clinical Evaluation Plan Requirements to Consider
The key requirements that must be considered before planning a clinical evaluation or more into developing the strategy for the clinical evaluation based on which the foundation of the EU MDR clinical evaluation plan can be laid.
- Identification of overarching safety and performance prerequisites from Annex I of MDR, necessitating the backing of clinical data.
- Clearly defined device intended use.
- Precise specification of target user groups, including explicit indications and contraindications.
- Comprehensive account of anticipated clinical benefits, accompanied by specific and relevant clinical outcome parameters.
- Definition of methodologies to assess both qualitative and quantitative aspects of clinical safety, with explicit reference to residual risks and potential side effects.
- Indicative outline and description of parameters for evaluating benefit-risk equilibrium, considering contemporary medical standards.
- Inclusion of strategies for addressing benefit-risk considerations.
- Inclusion of a clinical development roadmap that outlines progression from initial exploratory investigation to subsequent confirmatory investigations and post-market clinical follow-up, with milestones and potential criteria for each phase's advancement.
Clinical Evaluation Plan Medical Device Framework
The Contents of the EU MDR Clinical Evaluation Plan Framework defined in the MDR Annex XIV Part A are as follows:
- Device Overview: Present a comprehensive depiction of the medical device, detailing its purpose, approved uses, limitations, and risk category.
- Intended Purpose: Clarify the device's intended function, target user group, and highlight any specific application needing careful safety and performance consideration.
- Clinical Indication: Define the precise application of the device within the treatment scope, including user demographic, relevant precautions, contraindications, and method of use.
- Manufacturer's Claims: Outline the manufacturer's explicit statements regarding the device's clinical safety and performance attributes.
- Significant Risks: Address remaining risks with clinical implications.
- Current State-of-the-Art: Cover relevant norms and recommendations pertaining to current medical knowledge, exploring alternate medical options for the target audience, and identifying similar devices.
- Data Strategy and Analysis: Elaborate on the sources and categories of data to be incorporated in the clinical evaluation, highlighting the planned data generation strategies, with particular emphasis on literature reviews. Provide justification for the adequacy of data.
- Post-Market Surveillance Plan: Propose a well-defined approach for compiling post-market surveillance and post-market clinical follow-up information. Justify any decisions to waive these requirements.
By incorporating these essential elements, the Clinical Evaluation Plan (CEP) ensures a robust and systematic assessment of medical devices, enhancing patient safety and facilitating regulatory compliance with the Medical Device Regulation in the European Union.
Freyr is a trusted partner that offers comprehensive support to manufacturers in the development and execution of their Clinical Evaluation Plans (CEP). Freyr ensures that manufacturers have well-designed and scientifically sound CEPs that meet the necessary criteria for device approval and compliance. With Freyr's expertise and guidance, manufacturers can navigate the complexities of clinical evaluation and evidence generation, thereby achieving successful regulatory outcomes for their medical devices.
- End-to-end Clinical Evaluation Report writing support, including systematic literature search, as per MEDDEV 2.7/1 revision 4 and the EU Medical Device Regulation (MDR).
- Deriving a clinical evaluation plan specific to therapeutic area and/or risk class of the device.
- Identify, search, analyze, and put together the appropriate clinical data sources applicable.
- Develop a Clinical Evaluation Plan template and Clinical Evaluation Report template for your organization.
- Gap Analysis for existing Clinical Evaluation Report.
- Handling periodic updates of existing Clinical Evaluation Reports, as per the EU MDR guidelines.
- PMS data support for existing devices in the market.
- PER writing support for your IVDs.
- CE Marking Compliance and CE Marking services.
- Maintenance of a large quantity of literature and citation through advanced citation manager
- Assured compliance with recent applicable regulations.
- Team of qualified experts.
- Tailored Solutions to your requirements
- Regulatory Resource Management/Staff Augmentation Services
- Cross-functional inputs from Medical Device experts to comply with requirements.